CompletedPhase 2

A 10-week Efficacy Study of NOE-105 in Childhood Onset Fluency Disorder (Orpheus)

United States75 participantsStarted 2022-07-25

Plain-language summary

This study is designed to evaluate the effectiveness of NOE-105 on speech fluency without the known antipsychotic-induced side effects of commonly used treatments for childhood onset fluency disorder (COFD).

Who can participate

Age range18 Years – 55 Years

SexMALE

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Inclusion criteria

✓. Patients must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
✓. Patients who satisfy DSM-5 criteria for childhood onset fluency disorder and are suitable for pharmacotherapy.
✓. Have a history of stuttering for more than or equal to ≥ 2 years with onset consistent to developmental in nature before age 8 years.
✓. Patient reported global stuttering experience as "moderate" at screening and baseline.

Exclusion criteria

✕. BMI within the range 19 to 35 kg/m2 (inclusive).
✕. Male Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
✕. Capable of giving signed informed consent
✕. Able to read and write in English
✕. Stuttering is related to a known neurological cause eg, stroke, etc.
✕. Low IQ in the opinion of the investigator.
✕. Patients with uncontrolled seizure disorders.
✕. A history of severe traumatic brain injury or stroke.

What they're measuring

Change From Baseline to End of 6 Weeks in Total MLGSSS

Timeframe: 43 days

Trial details

NCT IDNCT05583955

SponsorNoema Pharma AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-20

Results submitted2025-11-24

View on ClinicalTrials.gov More Childhood-Onset Fluency Disorder trials